A double-blind crossover study comparing prophylactic intravenous granisetron alone or in combination with dexamethasone as antiemetic treatment in controlling nausea and vomiting associated with chemotherapy

European Journal of Cancer

Volumn 33, Issue 10, 1997, Pages 1605-1610

  Kirchner, V ^a   Aapro, M ^b   Terrey, J P ^c   Alberto, P ^a  

^a GENEVA UNIVERSITY HOSPITALS   (Switzerland)

^b CLINIQUE DE GENOLIER   (Switzerland)

^c SmithKline Beecham ^*  (Switzerland)

Author keywords

Antiemesis; Chemotherapy; Dexamethasone; Intravenous granisetron; Prophylaxis

Indexed keywords

ANTINEOPLASTIC AGENT; CARBOPLATIN; CISPLATIN; CYCLOPHOSPHAMIDE; DACARBAZINE; DEXAMETHASONE; DOXORUBICIN; GRANISETRON; PLACEBO;

ADULT; AGED; ARTICLE; ASTHENIA; CANCER CHEMOTHERAPY; CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DOUBLE BLIND PROCEDURE; DRUG CHOICE; DRUG EFFICACY; DRUG MIXTURE; DRUG RESPONSE; DRUG SCREENING; DRUG TOLERABILITY; FEMALE; HUMAN; INSOMNIA; INTRAVENOUS DRUG ADMINISTRATION; MAJOR CLINICAL STUDY; MALE; MALIGNANT NEOPLASTIC DISEASE; NAUSEA; PATIENT ATTITUDE; PRIORITY JOURNAL; PROPHYLAXIS; RANDOMIZED CONTROLLED TRIAL; VOMITING;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ANTIEMETICS; ANTINEOPLASTIC AGENTS; CROSS-OVER STUDIES; DEXAMETHASONE; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; FEMALE; GLUCOCORTICOIDS; GRANISETRON; HUMANS; MALE; MIDDLE AGED; NAUSEA; PATIENT SATISFACTION; SEROTONIN ANTAGONISTS; TREATMENT OUTCOME; VOMITING;

EID: 0031408939     PISSN: 09598049     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0959-8049(97)00160-3     Document Type: Article

References (38)

1. Coates A, Abraham S, Kaye S, et al. On the receiving end -patient perception of the side effects of cancer chemotherapy. Eur J Clin Oncol 1983, 19, 203-208.
2. Laszlo J. Emesis as limiting toxicity in cancer chemotherapy. In Laszlo J, ed. Antie-emetics and Cancer Chemotherapy. Baltimore/ London, Williams & Wilkins, 1983, 1-5.
3. Gralla RJ. An outline of anti-emetic treatment. Eur J Cancer Clin Oncol (Suppl 1) 1989, 25, S7-S11.
4. Winokur SM, Baker JJ, et al. Dexamethasone in the treatment of nausea and vomiting from cancer and chemotherapy. J Med Assoc Ga 1981, 70, 263-264.
5. Chiara S, Campora E, Lionetto R, Bruzzi P, Rosso R. Methylprednisolone for the control of CMF-induced emesis. Am J Clin Oncol (CCT) 1987, 10, 264-267.
6. Roila F, Tonato M, Basurto C, Minora V, Ballatori E, Del Favero A. Double-blind controlled trial of the antiemetic efficacy and toxicity of methylprednisolone (MP), metoclopramide (MTC) and domperidone (DMP) in breast cancer patients treated with i.v. CMF. Eur J Cancer Clin Oncol 1987, 23, 615-617.
7. Roila F, Basurto C, Minotti V, Ballatori E, Tonato M, Del Favero A. Methylprednisolone versus metoclopramide for prevention of nausea and vomiting in breast cancer patients treated with intravenous cyclophosphamide methotrexate 5-fluorouracil: a double-blind randomized study. Oncology 1988, 45, 346-349.
8. Basurto C, Roila F, Bracarda S, Tonato M., Ballatori E, Del Favero A. A double-blind trial comparing antiemetic efficacy and toxicity of metoclopramide versus methylprednisolone versus domperidone in patients receiving doxorubicin chemotherapy alone or in combination with other antiblastic agents. Am J Clin Oncol (CCT) 1988, 11, 594-596.
9. Markman M, Sheidler V, Ettinger DS, Quaskey SA, Mellits ED. Antiemetic efficacy of dexamethasone. Randomized, double-blind, crossover study with prochlorperazine in patients receiving cancer chemotherapy. N Engl J med 1984, 311, 549-552.
10. Pollera CF, Nardi M, Marolla P, Pinnaró P, Terzoli E, Giannarelli D. Effective control of CMF-related emesis with high-dose dexamethesone: results of a double-blind crossover trial with metoclopramide and placebo. Am J Clin Oncol (CCT) 1989, 12, 524-529.
11. 3 antagonist, versus a standard regimen of chlorpromazine plus dexamethasone in the treatment of cytostatic-induced emesis. Eur J Cancer (Suppl 1) 1990, 26, 28-32.
12. Warr D, Willan A, Fine S, et al. Superiority of granisetron to dexamethasone plus prochlorperazine in the prevention of chemotherapy-induced emesis. J Natl Cancer Inst 1991, 18, 1169-1173.
13. Granisetron Study Group. The antiemetic efficacy and safety of granisetron compared with metoclopramide plus dexamethasone in patients receiving fractionated chemotherapy over 5 days. Cancer Res Clin Oncol 1993, 119, 555-559.
14. Carmichael J, Bessel EM, Harris AL, Hutcheon AW, Dawes PJDK, Daniels S. Comparison of granisetron alone and granisetron plus dexamethasone in prophylaxis of cytotoxic-induced emesis. Br J Cancer 1994, 70, 161-1164.
15. Italian Group for Antiemetic Research. Dexamethasone, granisetron, or both for the prevention of nausea and vomiting during chemotherapy for cancer. N Engl J Med 1995, 332, 1-5.
16. Smith IE, Granisetron Study Group. Anti-emetic treatment with granisetron in patients receiving moderately emetogenic chemotherapy. Eur J Clin Res 1994, 5, 193-202.
17. Blijham GH on behalf of the Granisetron Study Group. Does granisetron remain effective over mutiple cycles? Eur J Cancer (Suppl 1) 1992, 28A, S17-S21.
18. Scmoll H-J. The role of ondansetron in the treatment of emesis induced by non-cisplatin-containing chemotherapy regimes. Eur J Cancer (Suppl 1) 1989, 25, S53-S39.
19. Bonneterre J, Chevallier B, Metz R, et al. A randomized double-blind comparison of ondansetron and metoclopramide in the prophylaxis of emesis induced by cyclophosphamide, fluorouracil, and doxorubicin or epirubicin chemotherapy. J Clin Oncol 1990, 8, 1063-1069.
20. Portuguese Ondansetron Study Group. Ondansetron in the treatment of nausea and vomiting induced by chemotherapy. Anticancer Drugs (Suppl 2) 1993, 4, 23-27.
21. Jantunen IT, Flander M, Heikkinen MI, Kuoppala TA, Teerenhovi L, Kataja W. Comparison of ondansetron with customary treatment in the prophylaxis of nausea and emesis induced by non-cisplatin containing chemotherapy. Acta Oncol 1993, 32, 413-415.
22. Jones AL, Hill AS, Soukop M, et al. Comparison of dexamethasone and ondansetron in the prophylaxis of emesis induced by moderately emetogeic chemotherapy. Lancet 1991, 338, 483-487.
23. Rosso R, Campora E, Cetto G, Fosser V, Marangolo M, Olivia C. Oral ondansetron (GR 38032F) for the control of acute and delayed cyclophosphamide-induced emesis. Anticancer Res 1991, 11, 937-940.
24. Fox SM, Einhorn LH, Cox E, Powell N, Abdy A. Ondansetron versus ondansetron, dexamethasone, and chlorpromazine in the prevention of nausea and vomiting associated with multiple-day cisplatin chemotherapy. J Clin Oncol 1993, 11, 2391-2395.
25. Soukop M, McQuade B, Hunter E, et al. Ondansetron compared with metoclopramide in the control of emesis and quality of life during repeated chemotherapy for breast cancer. Oncology 1992, 49, 295-304.
26. Campora E, Giudici S, Merlini I, Rubagotti A, Rosso R. Ondansetron and dexamethasone versus standard combination antiemetic therapy. A randomized trial for the prevention of acute and delayed emesis induced by cyclophosphamide-doxorubicin chemotherapy and maintenance of antiemtic effect at subsequent courses. Am J Clin Oncol (CCT) 1994, 17, 522-526.
27. Kamanabrou D, the Granisetron Study Group. Intravenous granisetron - establishing the optimal dose. Eur J Cancer (Suppl 1) 1992, 28A, S6-S11.
28. 3 receptor antagonist on cyclophosphamide induced vomiting in the ferret. Br J Cancer 1990, 61, 56-60.
29. Marr HE, Davey PT, Blower PR. The effect of dexamethasone, alone or in combination with granisetron, on cisplatin-induced emesis in the ferret. Br J Pharmacol 1991, 104, 371P.
30. Cunningham D, Turner A, Hawthorn J, Rosin RD. Ondansetron with and without dexamethasone to treat chemotherapy-induced emesis. Lancet 1989, i, 1323.
31. Smith DB, Newlands ES, Spruyt OW, et al. Ondansetron (GR38032F) plus dexamethasone: effective anti-emetic prophylaxis for patients receiving cytotoxic chemotherapy. Br J Cancer 1990, 61, 323-324.
32. France LA, Lewis JA, Kay R. The analysis of failure time data in crossover studies. Stat Med 1991, 10, 1099-1113.
33. Hesketh PJ, Kris MG, Grunberg SM, et al. A proposal for classifying the acute emetogenicity of cancer chemotherapy. J Clin Oncol 1997, 15, 103-109.
34. David M, Durrand M, Chauvergne J, Mauriac L, Bue NB, Hoerni B. Cyclophosphamide, methotrexate and 5-FU (CMF) induced nausea and vomiting: a controlled study with high-dose metoclopramide. Cancer Treat Rep 1984, 68, 921-922.
35. Morran C, Smith DC, Anderson DA, McArdle CS. Incidence of nausea and vomiting with cytotoxic chemotherapy: a prospective randomized trial of antiemetics. BMJ 1979, 1, 1323-1324.
36. D'Aquisto R, Tyson LB, Gralla RJ, et al. The influence of a chronic alcohol intake on chemotherapy-induced nausea and vomiting [Abstract]. Proc Am Soc Clin Oncol 1986, 5, 257.
37. Nicolai N, Mangiarotti B, Salvioni R, Piva L, Faustini M, Pizzocaro G. Dexamethasone plus ondansetron versus dexamethasone plus alizapride in the prevention of emesis induced by cisplatin-containing chemotherapies for urological cancers. Eur Urol 1993, 23, 450-456.
38. Räth U, Upadhyaya BK, Arechavala E, et al. Role of ondansetron plus dexamethasone in fractionated chemotherapy. Oncology 1993, 50, 168-172.